1. Field of the Invention
This invention relates to the field of medical devices, and more specifically, to an endotracheal intubation device.
2. Prior Art
The need to remove meconium from a newborn infant is well recognized. Reference is made to articles published in the (i) Journal of Pediatrics, Dec. 1974, Vol. 85, No. 6, pp. 848-852 entitled "Meconium Aspiration in Infants--A Perspective Study", and (ii) AM. J. Obstet. Gynecol. 126:712, 1976, entitled "Combined Obstetric and Pediatric Approach to Prevent Meconium Aspiration Syndrome". In that latter article, Meconium Aspiration Syndrome (MAS) is indicated to be a variety of aspiration pneumonia which occurs most frequently in term or past-term newborn infants who have passed meconium in utero. The article indicates that such infants often develop progressive respiratory failure with significant hypoxemia during the first two-to-three days of life. Death rates as high as 28% have been reported for MAS. Indicated in the article is what is believed to be one of the most up-to-date methods for removing meconium from the newborn infant; to-wit: tracheal suction under direct laryngoscopic vision as soon as possible after the birth of the at-risk infant.
Intrapartum nasopharyngeal suction has also been added as an additional technique. Generally, as soon as the baby's head appears on the perineum, and prior to delivery of the shoulders, the doctor passes a suction catheter through the nares to the level of the nasopharynx and aspirates any mucous or meconium. The doctor then suctions the mouth and hypopharynx in a similar manner. Because the field into which the catheter is being passed (i.e., a baby's mouth and nose) is small, and irregular in shape, a flexible tubing is often used. Following the delivery, the doctor, with the aid of a laryngoscope, shines light and visualizes the area directly above and below the vocal cords looking for meconium. If it is present, it must be removed by a suction device (usually a standard endotracheal (E-T) tube often requiring an internal guide wire) as quickly as possible to try to avoid greater or deeper aspirations of this material.
Because proper placement of the E-T tube is critical, the infant is held in position and a doctor or other hospital personnel then inserts the E-T tube which may have a stiffening or guide wire inserted therein. The stiffening wire enables the otherwise flexible tube to be more readily inserted into the trachea. The stiffening wire is needed depending upon (i) the preference of the user, (ii) the positioning of the baby, and (iii) the difficulty of passing the E-T tube into the trachea which may be due to the angulation of the particular baby's oropharynx and trachea position or because the baby is struggling. Once in proper position, the stiffening wire must be removed in order to allow the doctor to suck out any meconium in the trachea region. The doctor places his mouth over the proximal end of the E-T tube while it is located in the trachea. Suction is achieved by, in effect, inhaling. Once this is done, the E-T tube is removed. If meconium is found in the tube, the doctor must reinsert the E-T tube in the trachea, again with the guide wire stylet, if desired, and repeat the suction process as often as needed until no further meconium is retrieved.
The problems with this approach are obvious. First, suction cannot be applied until the intubation process is complete and the guide wire, if used, is removed. This means that meconium and secretions above the cord cannot be suctioned without using a separate suction device. Further, the intubation process must sometimes be interrupted, time must be taken to suction the oropharynx (often just to see the tracheal opening) then the intubation process must be reinitiated. Secondly, since the mouth of the user is used to created the suction, this can lead to accidental ingestion. Third, the process must be repeated until all meconium is removed. The reintubation process requires the use of precious time until ventilation of the distressed infant can be initiated.
In response to these problems, the instant inventor developed a device which is set forth in U.S. Pat. No. 4,275,724, the disclosure of which is herein incorporated by reference. As set forth in the '724 patent, an endotracheal intubation device is disclosed which enables the user to simultaneously apply suction during the intubation process. By the use of that device, both the upper airways as well as the trachea region could be cleaned using a single apparatus.
While the '724 device does have a number of benefits, the present invention is directed to yet further improvements over the state-of-the-art. First, the device of the present invention permits the user to very accurately control the suction being applied, but without risk of ingesting meconium. The need for accurate control is well recognized. The need to prevent inhalation is a more recent problem. There is presently (the 1980', recognized to be an "AIDS" epidemic. The vertical transmission of this disease has been well documented from mother to unborn infant. Blood, as well as cervical and vaginal secretions, have all been shown to potentially carry this infectious virus. The references include Hospital Practice, Jun. 15, 1986, p. 127-155; "AIDS: What is Now Known II, Epidemiology."
Thus, the secretions of an infected newborn could potentially act as an infectious source of contamination and exposure to hospital personnel which come in contact with this material. Not only is the baby at risk because of the ingestion of meconium, but should a doctor ingest any of the meconium, then the doctor may face some risk of being exposed to AIDS virus, or some other communicable disease as well. Further, meconium is a nasty smelling and unpalatable material, and there may be some apprehension among doctors to apply direct suction. This is magnified enormously if there is a potential problem with contracting AIDS.
There also exists the risk of the user transmitting an infectious disease to the infant during the application of the user's mouth to the suction device. Pediatric Infectious Disease, Vol. 2, No. 2, Mar. 1984 Van Dyke, Russell, B., "Transmission of Herpes Simplex Virus, Type 1, To a New Born Infant During Endotracheal Suctioning For Miconium Aspirations."
The device of the present invention is also very straightforward in its design, and can be made at a relatively low cost. In addition, the device can be easily removed from the E-T tube after suction is completed, and if desired the E-T tube joined to a source of positive air pressure. Thus, the device can be used to achieve quick insertion of an E-T tube for purpose of meconium removal, or for supplying air during resuscitation.
One further advantage of the present device is that it permits suction of the oropharynx and mouth during the intubation process, but still permitting the user to gain those advantages associated with the use of a guide wire.
These and other advantages are achieved, while still permitting the device to be used and held in one hand, thereby freeing the other hand for holding a laryngoscope.